Micronics, Inc., and Xtrana, lnc., will develop an inexpensive point of care cancer marker detection device. The device will integrate and automate blood sample preparation, cell sorting and enrichment by microcytometry, antigen (CD marker) analysis, and both DNA sequence and gene expression analysis. Micronics has developed a technology platform for performing microfluidic processes on laminate-based disposables. The technology comprises microfluidic cartridges assembled from plastic laminates, a computer-controlled fluid driver system, pneumatic and passive on-chip valving capability using accurate Iow-pulsatility pumps, and computer software to control fluid motion in the cartridge. Xtrana has developed a novel series of products and applications centered around unique capabilities in nucleic acid sample preparation. Key to the sample preparation is a family of materials, referred to as Xtra Bind, that bind nucleic acids essentially irreversibly, but still allow the bound DNA or RNA to be amplified using conventional methods like PCR. The project will require research and proof-of-principle experiments in the area of microfluidic cell marker identification and sorting, as well as in on-chip cell lysing and microfluidics-based nucleic acid amplification and detection. Specifically, experiments involving fluorescence detection on micro-cytometer card, accurate counting and display of fluorescent beads of different sizes as well as beads conjugated with antigen, tagged by antibody and counted on micro-cytometer will be performed initially, followed by sorting/fluorescence gating on micro-cytometer. At the same time, Xtrana will develop the protocols for the Xtra BindTM BCR/ABL mRNA expression measurement and will experimentally determine limit of detection and linear range of detection of bcr/abl mRNA transcripts for control cell lines spiked into white blood cells or blood. In Phase II, an instrument capable of BCR/ABL gene translocation diagnostic of chronic myeloid leukemia (CML) and the associated chimeric mRNA expression will be developed.